EP3413949A1 - Dispositif de logement de pompe sanguine - Google Patents

Dispositif de logement de pompe sanguine

Info

Publication number
EP3413949A1
EP3413949A1 EP17705072.1A EP17705072A EP3413949A1 EP 3413949 A1 EP3413949 A1 EP 3413949A1 EP 17705072 A EP17705072 A EP 17705072A EP 3413949 A1 EP3413949 A1 EP 3413949A1
Authority
EP
European Patent Office
Prior art keywords
pump
housing device
blood
valve
actuation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP17705072.1A
Other languages
German (de)
English (en)
Other versions
EP3413949B1 (fr
Inventor
Azad Najar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Scandinavian Real Heart AB
Original Assignee
Scandinavian Real Heart AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Scandinavian Real Heart AB filed Critical Scandinavian Real Heart AB
Publication of EP3413949A1 publication Critical patent/EP3413949A1/fr
Application granted granted Critical
Publication of EP3413949B1 publication Critical patent/EP3413949B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/89—Valves
    • A61M60/892—Active valves, i.e. actuated by an external force
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/835—Constructional details other than related to driving of positive displacement blood pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/196—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body replacing the entire heart, e.g. total artificial hearts [TAH]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/258—Piston pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/408—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
    • A61M60/411—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/424—Details relating to driving for positive displacement blood pumps
    • A61M60/438—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being mechanical
    • A61M60/441—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being mechanical generated by an electromotor
    • A61M60/443—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being mechanical generated by an electromotor with means converting the rotation into a translational movement of the displacement member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/89—Valves
    • A61M60/894—Passive valves, i.e. valves actuated by the blood

Definitions

  • the present disclosure relates to a blood pump housing device arranged to receive and enclose a Total Artificial Heart (TAH) when implanted inside a subject.
  • TAH Total Artificial Heart
  • the main function of the heart in the human body is to circulate blood through the blood vessels in order to transport oxygen, nutrition, and waste products to and from body cells.
  • Many diseases may affect the heart such as myocardial infarction, hypertension, valve insufficiency and various heart muscle diseases.
  • the end result of such diseases may be heart failure which means that the heart has lost its ability to pump enough blood to the lungs and body tissues.
  • heart failure The symptoms of heart failure are shortness of breath, edema and fatigue.
  • the only treatment option available for a patient suffering from advanced heart failure is heart transplantation.
  • heart transplantation due to a lack of sufficient number of donor hearts the majority of advanced heart failure patients die while waiting for a heart transplant operation.
  • TAH Total Artificial Hearts
  • WO2016/020219 discloses a four-chambered TAH which is designed as a human heart.
  • This TAH comprises a first and a second artificial heart pump corresponding to the left and right heart of the natural heart.
  • Each pump comprises a valve cylinder which is divided into two chambers by means of a moving plane comprising a one-way valve which corresponds to the Atrioventricular (AV) plane in a natural heart.
  • AV Atrioventricular
  • Pump actuating means are configured to apply a movement to said valve cylinders in an upward and downward direction in response to control signals from a control unit such that when the valve cylinders move in an upward direction inside the blood pump housing device, the valves provided in the valve planes are in an open position allowing a flow of blood from the artificial atrium into the artificial ventricle, and when the valve cylinders move in a downward direction the valves are in the closed position and blood is ejected from the artificial ventricle and exit therefrom through outlet channels.
  • the TAH When implanted in a subject it is important that the TAH is enclosed in a casing which protects the surrounding tissue from moving parts but it is also important that it prevents entry of body fluids into the TAH.
  • a further object has been to provide a blood pump housing device which will also facilitate the implantation of the TAH in the subject and any
  • the present invention relates to a blood pump housing device designed to enclose and protect a total artificial heart when implanted in a subject.
  • the blood pump housing device as disclosed herein is advantageously designed to receive, enclose and protect a four-chambered total artificial heart comprising a first and a second artificial heart pump corresponding to the left and right heart of the natural heart together with a first and second pump actuating means for inducing a blood flow in a body's vascular system.
  • the blood pump housing device comprises, a first and second artificial heart pump receiving part configured to receive and partly enclose said first and second artificial heart pumps.
  • the blood pump housing device further comprises a first and second pump actuation enclosing part configured to at least partly enclose said first and second pump actuation means.
  • Said first and second pump actuation parts are advantageously connected to said first and second pump enclosing parts in a leak-free manner. Together the four parts form the blood pump housing device.
  • the blood pump housing device Separating the blood pump housing device into four parts facilitates the assembly of the four- chambered total artificial heart during manufacture, and especially during implantation of the total artificial heart in a subject.
  • the first and second artificial heart pump receiving parts and the first and second pump actuation enclosing parts may be assembled together by connecting means selected from the group consisting glue, connecting screws, bolts and nuts, clamps and/or clips.
  • the connections between the pump receiving parts and pump actuation enclosing parts must be leak-free in order to prevent entry of body fluids into the artificial heart pump.
  • the two artificial heart pump receiving parts may be provided as separate units but are advantageously interconnected.
  • Each pump receiving part is configured to receive and enclose a valve cylinder of the artificial heart pump which is movably arranged inside the pump receiving part.
  • the inside of the valve cylinder is separated by a valve plane provided with a valve which is housed inside the valve cylinder.
  • the valve plane is arranged in the valve cylinder, such that the valve plane divides the valve cylinder into two parts, one upper part and one lower part.
  • first artificial heart pump and the second artificial heart pump are identical and the valves provided in the valve cylinders of each artificial heart pump correspond to the mitral valve on the left side of the natural heart and the tricuspid valve on the right side.
  • Each pump receiving part has an upper open end and a lower open end.
  • the upper open end is arranged with an upper cover provided with an inlet channel.
  • the upper cover together with the upper part above the valve plane of the valve cylinder forms an artificial atrium corresponding to an atrium of the natural heart.
  • the lower open end of the pump receiving part is arranged with a lower cover provided with an outlet channel, which together with the lower part below the valve plane of the valve cylinder forms an artificial ventricle
  • the outlet channels are provided with one- way valves to ensure a unidirectional flow of blood through the artificial heart pumps.
  • the upper and lower covers are arranged onto the upper and lower open ends of the pump receiving parts in a leak-free manner.
  • the upper and lower covers are glued to the upper and lower open ends.
  • a gasket made from a biocompatible rubber or silicon material is arranged between the covers and the valve cylinder casings.
  • the upper and lower covers may also be fastened onto the valve cylinder casings by means of connecting screws, bolts and nuts, clamps and/or clips.
  • the pump receiving parts and the pump actuation enclosing parts of the blood pump housing device are advantageously made from a stiff material, such as e.g. a biocompatible material such as, titanium, ceramics, Polytetrafluoroethylene (PTFE) coated metal, diamond coated metal, silicone or polyurethane coated metals or a combination thereof.
  • a stiff material such as e.g. a biocompatible material such as, titanium, ceramics, Polytetrafluoroethylene (PTFE) coated metal, diamond coated metal, silicone or polyurethane coated metals or a combination thereof.
  • PTFE Polytetrafluoroethylene
  • the inside of the artificial atriums and ventricles are provided with a flexible lining material made from plastic or rubber.
  • the flexible lining may also be comprised of two or more layers of lining material to improve its strength.
  • two electrodes could be placed between the first layer and the second layer to send an alarm if the first layer is partially or totally damaged and blood can be detected between these two layers.
  • the flexible lining material is advantageously made from a biocompatible material like silicone, polyurethane or another biocompatible material.
  • the flexible lining material is in the artificial atrium connected to an upper cylinder junction arranged between the upper cover and the top edge of the upper open end of the pump receiving part by the use of biocompatible glue or other means to prevent any leakage through the upper cylinder junction.
  • the flexible lining material is also in the artificial ventricle connected to a lower cylinder junction arranged between the lower cover and the bottom edge of the lower open end of the pump receiving part by the use of biocompatible glue or other means to prevent any leakage through the lower cylinder junction.
  • the outlet channels of the four-chambered total artificial heart are located on the lower covers and provided with one-way outlet valves to prevent the return of blood back into the artificial ventricle after the blood has been ejected through the outlet channel.
  • the outlet channel valves correspond to the aortic valve or the pulmonary valve respectively of the natural heart.
  • a leak-free pipeline is formed in the artificial heart through which blood is pumped in a continuous pulsating flow from the entrance of the inlet channel through the artificial atrium, the valve, the ventricle and out through the outlet channel .
  • the TAH further comprises a first and second pump actuation means configured to apply movement to the valve cylinders of the first and second pumps.
  • the pump actuating means are received into and at least partly enclosed by the pump actuation enclosing parts.
  • the pump actuation enclosing parts each comprise pump actuation casing configured to receive and enclose a pump actuating means.
  • the two pump actuation casings are interconnected.
  • the pump actuation enclosing parts with the pump actuation casings are configured to dock to docking apertures provided on the first and second pump enclosing parts such that said first and second pump actuating means enclosed therein may apply movement to the valve cylinders of the artificial heart pumps in an upward and downward direction in response to control signals from a control unit.
  • the pump actuation enclosing parts with pump actuation casings dock to the docking apertures in a leek free manner to prevent body fluids from entering the blood pump housing device.
  • the pump actuation enclosing parts are docked to the docking apertures by means of connecting means selected from the group consisting of glue, connecting screws, bolts and nuts, clamps and/or clips.
  • connecting means selected from the group consisting of glue, connecting screws, bolts and nuts, clamps and/or clips.
  • first and second pump actuation casings of the pump actuation enclosing part are connected to the docking apertures in a reversible manner such that the pump actuation enclosing part is easily removed if the pump actuation means requires maintenance.
  • Connecting means such as connecting screws, bolts and nuts, clamps and/or clips facilitate opening and closing of the blood pump housing device and are therefore preferred.
  • a gasket is provided in the junction between the first and second pump actuation casings and the docking apertures.
  • the pump actuating means are configured to apply movement to said valve cylinders in an upward and downward movement inside the pump receiving parts in response to control signals from a control unit.
  • the valve cylinders move in an upward direction, the valves provided in the valve planes are in an open position allowing a flow of blood from the artificial atrium into the artificial ventricle.
  • the valve cylinders move in a downward direction the valves are in the closed position and blood is ejected from the artificial ventricles and exit therefrom through the outlet channels.
  • Each artificial heart pump contains a pump actuating means and both the first and the second artificial heart pumps of the heart operate simultaneously and in the same direction.
  • the upward and downward motion of the valve cylinders may be achieved in many different ways.
  • the pump actuation means actuates rotation of a series of gears interconnected to a rack and pinion.
  • the pump actuation means is
  • a plurality of gears of different sizes is configured to interact with one another and an interconnected pinion.
  • Said interconnected gears and pinions translate said rotational movement to a first and second linear toothed means such as e.g. a rack, provided on each side of the valve cylinder.
  • a first and second linear toothed means such as e.g. a rack, provided on each side of the valve cylinder.
  • teeth provided on the pinion interact with teeth on a linear toothed gear (i.e. the rack) provided on the each side of the cylinder and causes the linear rack with the valve cylinder to move relative to the pinion in a first linear direction.
  • the pump actuation means changes direction into a second rotational direction opposite to said first rotational direction and moves said valve cylinder in a second linear direction opposite to said first linear direction.
  • the rotational speed and length of rotational movement is adjusted to provide appropriate speed and length of the up-and-down movement of the valve cylinders to induce correct blood flow through the TAH and into the vascular system.
  • the pump actuating means comprises a ball screw or a roller screw which translates a rotational motion provided by a pump actuation means, such as e.g. an electromechanical motor into a linear up-and-down motion of the valve cylinders.
  • a pump actuation means such as e.g. an electromechanical motor into a linear up-and-down motion of the valve cylinders.
  • Said pump actuation means actuates rotational movement of a plurality of gears which interact with said ball screws/roller screws.
  • Said ball screw/roller screw is interconnected with a semicircular base comprising two projecting arms which partly encircle said valve cylinders.
  • Each valve cylinder is provided with two or more magnets arranged to interact with magnets provided on said encircling arms.
  • the pump actuation means changes direction into a second rotational direction opposite to said first rotational direction and moves said ball screw /roller screw in a second linear direction opposite to said first linear direction thereby moving said valve cylinder in a second linear direction opposite to said first linear direction.
  • the rotational speed and length of rotational movement is adjusted to provide appropriate speed and length of the up-and- down movement of the valve cylinders to induce correct blood flow through the TAH and into the vascular system.
  • the energy to power the pump actuating means may be supplied by an external source via a cable through the skin, or alternatively by an implanted battery.
  • the implanted battery may be recharged from the outside via a cable or by means of induction or ultra sound.
  • the pump actuation enclosing part may further comprise a separate and detachable power source housing configured to store any power source used to power the pump actuation means such as rechargeable batteries.
  • the power source housing may also house any micro-computers and/or electronic chips used to receive signals from sensors in the artificial four-chambered heart or to control the pump actuation means.
  • the detachable power source housing may be removed without having to access any other part of the blood pump housing device.
  • the pump actuation means comprises several moving parts such as motors, electronics, gears and bearings that may have limited useful life.
  • the pump actuation means as well as the power source housing are integrated and together form the pump enclosing part.
  • This design of the blood pump housing device facilitates maintenance of mechanical parts and/or electronic control unit or change of batteries as the pump actuation enclosing part can easily be disassembled from the pump receiving part and exchanged for a new one. There is no need for long and time consuming surgery.
  • the connecting means connecting the pump actuation casings of the pump actuation enclosing part to the docking apertures are easily disassembled, the pump actuation enclosing part comprising the pump actuation means and maybe the power source is removed and exchanged for a new one.
  • the new pump actuation enclosing part is docked to the docking apertures of the pump receiving part and connected thereto by means of connecting means.
  • a first end of said inlet cuff is advantageously made from a wide strip of vessel graft tissue (e.g. Dacron material).
  • the second end of the inlet cuff is advantageously fitted with a fast connection such as a blocking stripe made from glass fiber reinforced silicone or other material used for this purpose. Alternatively some other fast connection can be used. Said fast connections connect to the inlet channels. Alternatively, collar cuffs may be glued to the inlet channels. The glue should be a biocompatible glue material.
  • the outlet channels of the four-chambered total artificial heart are advantageously connected to the aortic and pulmonary arteries by means of an outlet cuff analogous to the manner described for the inlet channels above.
  • a de-airing handle may be assembled to the valve cylinder casings of the artificial heart pump receiving part by means of screws.
  • the manual de-airing handle may manually operate the valve cylinder in an upward and downward direction to create a blood flow inside the first and second heart pumps thereby removing any air trapped in the system.
  • the surgeon disassembles the manual de-airing handles from the valve cylinder casings and instead assembles the pump actuation enclosing parts to operate the valve cylinder as described above. The surgeon will gradually close down the heart-lung machine to let the four-chambered total artificial heart circulate the blood instead of the diseased heart.
  • a further advantage with enclosing the first and second artificial heart pumps as well as the pump actuating means in a leak-free blood pump housing device as described herein is that all inlet channels to the artificial atriums as well as the outlet channels exiting the artificial ventricles are arranged on the outside of the blood pump housing. Thus, all artery grafts as described above are easily accessible without having to open the blood pump housing device.
  • Figure 1 is a view of the total artificial heart when arranged in the blood pump housing device.
  • Figure 2 is a view of the pump receiving parts when connected to the pump actuation casings.
  • Figure 3 is an exploded view of the blood pump housing device including artificial heart pumps and pump actuating means.
  • FIG. 4a is a detailed view of the valve cylinder and 4b is a view of the pump receiving parts
  • Figure 5 is cross sectional view of an artificial heart pump of the total artificial heart when fitted in a blood pumping device as described herein.
  • Figure 6 is a cross sectional view of the two artificial heart pumps of a Total Artificial Heart.
  • Figure 6a is a detailed view of the turning bend and the blood flow inside an artificial ventricle.
  • Figures 7a and b are views of the blood flow through the artificial heart during diastole (7a) and systole (7b).
  • Figures 8a-e are views of different cross-sectional shapes of the sharp bend inside the artificial ventricle.
  • Figure 9 is a perspective view of a first embodiment of the pump actuation means.
  • Figure 10 is a view of the pump actuation means, the valve cylinder and the pump receiving part.
  • Figure 1 1 is a view of the pump actuation means, the valve cylinder and the pump receiving part.
  • Figure 12 is a view of the first embodiment of the interaction between the pump actuation means and the valve cylinder.
  • Figure 13 is a view of the pump actuation means according to a first embodiment when docked to the pump receiving parts
  • Figure 14a is a detailed view of the pump actuating means according to a second embodiment and b is a view of pump actuating means according to a second embodiment when interacting with the valve cylinders.
  • Figure 15 is an exploded view of the pump actuation casing fitted with a detachable power storage casing.
  • Figure 16 is a view of the pump de-airing handle.
  • the total artificial heart 1 as described herein comprises a first and a second artificial heart pump 20a, 20b and first and second pump actuation means 60a, 60b enclosed in a blood pump housing device 2 (see figures 1 -3).
  • the first and second artificial heart pumps 20a, 20b are identical and correspond to the left and right side of a natural heart.
  • reference numbers denoting “a” refers to elements forming parts of the first artificial heart pump 20a and elements referred to as "b” form parts of the second artificial heart pump 20b.
  • the first pump actuation means 60a actuates movement of the first artificial heart pump 20a
  • the second pump actuation means 60b actuates movement of the second artificial heart pumps 20b to induce a blood flow in a body's vascular system.
  • the blood pump housing device 2 comprises two artificial heart pump receiving parts 3a, 3b and two pump actuation enclosing parts 4a, 4b (figure 3) connected together by connecting means 61 a, 61 b.
  • Each artificial heart pump receiving part 3a, 3b encloses an artificial heart pump 20a, 20b and each pump actuation enclosing part 4a, 4b at least partly encloses the first and a pump actuating means 60a, 60b
  • the first and second pump actuation means 60a, 60b actuate movement of the first and a second artificial heart pumps 20a, 20b to induce a blood flow in a body's vascular system.
  • the first and second artificial heart pumps 20a, 20b are identical and correspond to the left and right side of a natural heart.
  • Each artificial heart pump receiving part 3a, 3b encloses a valve cylinder 22a, 22b (figure 4a) movably arranged inside said pump receiving part 3a, 3b (figure 4b).
  • the pump receiving parts 3a, 3b are shown either connected or separated from each other.
  • Each pump receiving part 3a, 3b has an upper open end 6a, 6b and a lower open end 7a, 7b (see figure 4a).
  • Each pump receiving part 3a, 3b is also provided with a pump actuation docking aperture 8a, 8b.
  • the upper open ends 6a, 6b of the pump receiving parts 3a, 3b are fitted with upper covers 23a, 23b provided with inlet channels 24a, 24b.
  • the upper covers 23a, 23b together with the upper parts of the valve cylinders 22a and 22b form artificial atriums 25a, 25b corresponding to the atriums of the natural heart (see figures 5 and 6).
  • the lower open ends 7a, 7b of the pump receiving parts 3a, 3b are fitted with lower covers 26a, 26b provided with outlet channels 27a, 27b, which together with the lower parts of the valve cylinders 22a, 22b form artificial ventricles 28a, 28b corresponding to the ventricles of the natural heart.
  • the outlet channels 27a, 27b are provided with one-way valves 29a, 29b to ensure a unidirectional flow of blood through the artificial heart pumps 20a, 20b(figures 5 and 6).
  • valve planes 31 a, 31 b which are housed inside the valve cylinders 22a, 22b.
  • the valve planes 31 a, 31 b are provided with valves 32a, 32b and arranged in the valve cylinders 22a, 22b, such that the valve planes 31 a, 31 b divide the valve cylinders 22a, 22b into two parts, one upper part and one lower part (figures 5 and 6).
  • the upper and lower covers 23a, 23b and 26a, 26b are arranged in a leak-free manner onto the upper and lower open ends 6a, 6b and 7a, 7b respectively of the pump receiving part 3a, 3b.
  • the upper and lower covers 23a, 23b and 26a, 26b are glued to the upper and lower open ends 6a, 6b and 7a, 7b.
  • a gasket (not shown) made from a biocompatible rubber or silicon material is arranged between the covers and the upper and lower open ends 6a, 6b and 7a, 7b of the pump receiving parts 3a, 3b.
  • the first and second artificial heart pumps 20a, 20b are identical and the valves 32a, 32b provided in the valve cylinders 22a, 22b of each artificial heart pump 20a, 20b, correspond to the mitral valve 32a on the left side of the natural heart and the tricuspid valve 32b on the right side (figures 5 and 6).
  • Pump actuating means 60a, 60b are configured to apply a movement to said valve cylinders 22a, 22b in an upward and downward direction in response to control signals from a control unit (not shown) such that when the valve cylinders 22a, 22b move in an upward direction inside the blood pump housing device 2 (see figure 7a), the valves 32a, 32b provided in the valve planes 31 a, 31 b are in an open position allowing a flow of blood from the artificial atrium 25a, 25b to the artificial ventricle 28a, 28b, and when the valve cylinders 22a, 22b move in a downward direction (see figure 7b) the valves 32a, 32b are in the closed position and blood is ejected from the artificial ventricles 28a, 28b through the outlet channels 27a, 27b.
  • the internal structure of a natural ventricle has a sharp turn at the bottom of the ventricle i.e. at the apex of a natural heart, which forms a bend of approximately 1 10-150°. This means that when blood reaches the bottom of the apex it hits a stopping surface and most of the kinetic energy stored in the flowing blood which has flooded into the ventricle from the atrium through the open valve, is for a short moment transmitted to the heart muscle and thereafter transmitted back to the blood when the AV plane moves downward and pushes the blood from the ventricle. Next the blood leaves the heart through the aortic and pulmonary valves and continues into the aorta or the pulmonary arteries.
  • the stopping surface at the abrupt bend of the apex inside the ventricle makes the heart use less energy than expected considering that it has to pump a large volume of blood throughout the entire circulatory system.
  • the repeated deceleration and acceleration of the moving blood inside the ventricles creates a dynamic flow of blood preventing the formation of blood clots.
  • the artificial ventricles 28a, 28b of the four-chambered total artificial heart 1 as described herein comprise a turning portion 33a, 33b which mimics the design of the apex of a natural heart (see figure 8a).
  • a turning portion 33a, 33b which mimics the design of the apex of a natural heart (see figure 8a).
  • the turn at the inside of the turning portion 33a, 33b at the bottom of the lower cover 26a, 26b forms a sharp bend of approximately 90-340°, more preferably between 100- 300°, more preferably between 105-200°, and most preferably a bend between 1 10-150°, which is similar to the bend inside the ventricle of a natural heart.
  • the cross section of the sharp turn 33a, 33b inside the artificial lower cover 26a, 26b advantageously has a bi-channeled shape 34a, 34b (see figure 8e).
  • the term "bi-channeled shape” comprises a cavity cross-section which is oval with a waist to create two channels in the cavity of the ventricle.
  • the bi- channeled shape enables an optimal flow of the blood through the artificial ventricle 28a, 28b.
  • a bi-channeled cross-section 34a, 34b of the turning portion 33a, 33b in the lower cover 26a, 26b facilitates the formation of several channels inside the cavity of the artificial ventricle to allow the blood to hit a stopping surface 35a, 35b at the bottom part of the turning portion 33a, 33b in the lower cover 26a, 26b before it changes direction and exits through the outlet channels 27a, 27.
  • Figure 8a illustrates how the blood enters the lower part of the lower cover 26a, 26b in the artificial ventricle 28a, 28b, hits the stopping surface 35a, 35b and exits the ventricle 28a, 28b through the outlet channel 27a, 27b and outlet valve 30a, 30b.
  • Figures 6b-e is a view of the different cross sections the turning portion 33a, 33b may have to facilitate the flow towards the stopping surface 35a, 35b.
  • Figure 6a discloses a triangular shape
  • 6b discloses an oval shape
  • 6c discloses an oval shape with a waist
  • 6d discloses a circular shape.
  • the cross-sections of the turning portion 33a, 33b of the lower cover 26a, 26b may also have triangular, an oval shape 34 without a waist or a circular shape (see figures 8 b-d).
  • the inner walls of the artificial ventricles 28a, 28b as well as the outlet channels 27a, 27b are advantageously provided with rough surfaces 36a, 36b to simulate the trabeculae carneae, i.e. the muscular ridges that crisscross and project from the inner walls of the ventricles of a natural heart.
  • a rough surface 36a, 36b minimizes the formation of eddies in the blood flow next to the wall of the artificial ventricle 28a, 28b much like when water flows past an obstacle in a river.
  • the moving blood creates multiple swirls of blood close to the wall surface.
  • Such blood swirls run opposite to the main blood stream disrupting the flow and decreasing the speed of blood inside the ventricle.
  • a rough surface on the inside of the ventricles 28a, 28b and outlet channels 27a, 27 therefore minimizes the formation of blood swirls and further increases the speed of blood inside the artificial ventricle 28a, 28b of the four-chambered blood pumping device 1 .
  • the outlet of the ventricle in a natural heart has a diameter which decreases continuously towards the aorta or the pulmonary arteries.
  • the outlet channels 27a, 27b from the artificial ventricles 28a, 28b which are located in the lower covers 26a, 26b also have a diameter which decreases continuously similarly to the design of the outlet of a ventricle in a natural heart.
  • a rough inner surface 36a, 36b (figure 8a) together with a decreasing diameter of the outlet channel 27a, 27b will significantly increase the speed of the blood flow exiting the artificial ventricles 28a, 28b of the four-chambered total artificial heart 1 .
  • the artificial heart pump receiving parts 3a, 3b and pump actuation enclosing parts 4a, 4b of the blood pump housing device 2 are advantageously made from a stiff material, such as e.g. a biocompatible material such as, titanium, ceramics, Polytetrafluoroethylene (PTFE) coated metal, diamond coated metal, silicone or polyurethane coated metals or a combination thereof.
  • a stiff material such as e.g. a biocompatible material such as, titanium, ceramics, Polytetrafluoroethylene (PTFE) coated metal, diamond coated metal, silicone or polyurethane coated metals or a combination thereof.
  • PTFE Polytetrafluoroethylene
  • the insides of the artificial atriums 25a, 25b and ventricles 28a, 28b are provided with a flexible lining material 37a, 37b to prevent blood from leaking from the artificial heart pump (see figures 7a and 7b).
  • the flexible lining material 37a, 37b may also be comprised of two or more layers of material to improve its strength.
  • the flexible lining material 37a, 37b is advantageously made from a biocompatible material like silicone, polyurethane or another biocompatible material.
  • the flexible lining material 37a, 37b is connected to upper cylinder junctions between the upper covers 23a, 23b and the top edge of the valve cylinder casing upper open ends 6a, 6b to prevent any leakage through said upper cylinder junctions.
  • the flexible lining material 37a, 37b is also connected to the lower cylinder junctions between the lower covers 26a, 26b and the bottom edge of the valve cylinder casing lower open end 7a, 7b to prevent any leakage through the lower cylinder junctions.
  • the flexible lining material 37a, 37b is fixed to the upper and lower cylinder junctions e.g. by means of biocompatible glue or alternatively by screws.
  • a leak-free pipeline is formed in the artificial heart through which blood is pumped in a continuous pulsating flow from the entrance of the inlet channel 24a, 24b through the artificial atrium 25a, 25b, the valve32a, 32b, the ventricle 28a, 28b and out through the outlet channel 27a, 27b.
  • the outlet channels 27a, 27b of the four-chambered total artificial heart are provided with one-way outlet valves 30a, 30b to prevent the return of blood back into the artificial ventricles 28 after the blood has been ejected through the outlet channels 27a, 27b.
  • the one-way outlet channel valves 30a, 30b correspond to the aortic valve 30a or the pulmonary valve 30b respectively of the natural heart.
  • the first and second pump actuating means 60a, 60b are configured to apply movement to said valve cylinders 22a, 22b in an upward and downward direction in response to control signals from a control unit.
  • the first and second pump actuating means 60a, 60b are each at least partly housed by a pump actuation casing 65a, 65b which form part of pump actuation enclosing part 4a, 4b (see figure 3).
  • the two pump actuation casings 65a, 65b are connected together.
  • Each of the first and second pump actuation casings 65a, 65b are configured to receive and enclose a pump actuating means 60a, 60b and dock to docking apertures 8a, 8b provided on the pump receiving parts 3a, 3b.
  • said first and second pump actuating means 60a, 60b are configured to apply movement to the valve cylinders 22a, 22b in an upward and downward movement in response to control signals from a control unit.
  • the term "dock to" when used herein is intended to mean that the pump actuation casings 65a, 65b are configured to connect to the apertures 8a, 8b provided on the pump receiving parts 3a, 3b.
  • the pump actuation casings 65a, 65b dock to the pump receiving parts 3a, 3b in a leek free manner to prevent body fluids from entering the blood pump housing device 2.
  • the pump actuation casings 65a, 65b are docked to the docking apertures 8a, 8b by means of connecting means 61 a, 61 b selected from the group consisting of glue, connecting screws, bolts and nuts, clamps and/or clips.
  • first and second pump actuation casings 65a, 65b are connected to the docking apertures 8a, 8b in a reversible manner such that the pump actuation enclosing parts 3a, 3b are easily removed if the artificial heart pumps 20a, 20b or pump actuation means 60a, 60b require maintenance.
  • a gasket is provided in the connection between the first and second pump actuation casings 65a, 65b and the docking apertures 8a, 8b of the pump receiving parts 3a, 3b.
  • the pump actuation means 60a, 60b actuates rotation of a plurality of gears 67a, 67b (see figure 9) of different sizes configured to interact with one another and a pinion 69a, 69b to translate a rotational movement into a first and second linear toothed means 68a, 68b provided on each side of the valve cylinder 22a, 22b.
  • the pump actuation means changes direction into a second rotational direction opposite to said first rotational direction and moves said valve cylinder 22a, 22b in a second linear direction opposite to said first linear direction.
  • the rotational speed and length of rotational movement is adjusted to provide appropriate speed and length of the up-and-down movement of the valve cylinders 22a, 22b to induce correct blood flow through the TAH 1 and into the vascular system.
  • the pump actuating means 60a, 60b comprises a ball screw or a roller screw 62 which translates a rotational motion into a linear up-and-down motion of the valve cylinders 22a, 22b.
  • the ball screw or roller screw gear-box 62a, 62b translates a rotational motion provided by a pump actuation means into a linear up-and-down motion of the valve cylinders 22a, 22b inside the pump receiving parts 3a, 3b.
  • the nut of the ball or roller screw 62a, 62b is an integrated part of the pump actuating assembly and forms the base from which two arms 63a, 63b of the pump actuating means 60a, 60b extend around at least part of the valve cylinder 22a, 22b circumference and connect thereto.
  • the screw of the ball or roller screw 62a, 62b is provided with a first cogwheel 71 a, 71 b in a cooperative arrangement with a second cogwheel 72a, 72b with different diameter to form a gearbox, which in turn is connected to a motor cogwheel 73a, 73b of a pump actuation means, such as e.g. an electromechanical motor.
  • Each valve cylinder 22a, 22b is provided with two or more cylinder magnets 40a, 40b arranged to interact with actuation magnets 64a, 64b provided on the arms 63a, 63b.
  • Each artificial heart pump 20a, 20b contains a pump actuating means 60a, 60b and both artificial heart pumps 20a, 20b of the heart operate simultaneously and in the same direction ( Figures 14a and 14b).
  • the energy to power the pump actuating means 60a, 60b may be supplied by an external source via a cable through the skin, or alternatively by an implanted battery.
  • the implanted battery may be recharged from the outside via a cable or by means of induction or ultra sound.
  • Micro-computer or electronic chips configured to receive signals from pressure sensors may be arranged around major arteries or alternatively be integrated inside the cavity or the walls of the artificial atriums or ventricles or both. When the patient changes his physical activities the blood pressure will reflect the situation.
  • the micro-computer or electronic chips may also receive signals from an oxygen sector sensor arranged around major or minor arteries or alternatively integrated inside blood vessels.
  • the micro-computer or electronic chips may also receive signals from thermal sensors arranged around major arteries, integrated inside vessels or alternatively integrated anywhere in the chest cavity. The body temperature, which increases with physical activity, may also be used to activate the pump actuating means during high physical efforts.
  • the micro-computer or electronic chips may also receive signals from positional sensors arranged inside the four-chambered total artificial heart to reflect whether the patient is standing or lying down.
  • the micro-computer or the electronic chips will send information to the pump actuating means to change its pumping activity accordingly. If for some reason the micro-computer or electronic chips are not receiving any input information, the pump actuating means will continue at a constant level of activity, and instead the patient will have to adjust his physical activities.
  • the micro-computer or the electronic chips will advantageously be designed to send information and have the capability to communicate with a communicator such as a pocket device carried by the patient or to as an application in the patients smart mobile device.
  • a communicator such as a pocket device carried by the patient or to as an application in the patients smart mobile device.
  • the communicator may also send an alarm if something wrong occurred to the four-chambered total artificial heart, or reflect the status during use, the temperature of the electrical motor or when the pressure inside the Artificial atrium or ventricle exceed an upper limit.
  • the pump actuation enclosing parts 4a, 4b may comprise a separate and detachable power source casing 66a, 66b (see figure 15) configured to store any power source used to power the pump actuation means 60a, 60b such as rechargeable batteries.
  • the power source casings 66a, 66b may also house any micro-computers and/or electronic chips used to receive signals from sensors in the artificial four-chambered heart or to control the pump actuation means 60a, 60b.
  • a pump de-airing handle 80 (see Figure 16) may be assembled onto the docking apertures 8a, 8b in a leek free manner instead of pump actuation casings 65a, 65b.
  • Two de- airing arms 81 of the pump de-airing handle 80 extend around at least part of the valve cylinder 22a, 22b circumference and connect thereto.
  • Each arm of the pump de-airing handle 80 is provided with two or more magnets 82 arranged to interact with the cylinder magnets 40 provided on the valve cylinders 22a, 22b.
  • the pump de-airing handle 80 manually operate the artificial heart pump 20a, 20 during the implantation procedure.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
  • Prostheses (AREA)
  • Details Of Reciprocating Pumps (AREA)

Abstract

Un dispositif de logement de pompe sanguine conçu pour entourer et protéger un cœur artificiel total lorsqu'il est implanté dans un sujet est divulgué. Le dispositif de logement de pompe sanguine comprend une première et une seconde partie de réception de pompe cardiaque artificielle (3a, 3b) conçue pour recevoir et partiellement entourer une première et une seconde pompe cardiaque artificielle (20a, 20b) d'un cœur artificiel total (TAH); et une première et une seconde partie d'enceinte d'actionnement de pompe (4a, 4b) conçues pour entourer partiellement un premier et un second moyen d'actionnement de la pompe cardiaque artificielle (60a, 60b), lesdites parties de réception de pompe cardiaque artificielle (3a, 3b) et parties d'enceinte de moyens d'actionnement de pompe (4a, 4b) étant disposées pour se raccorder l'une à l'autre sans fuite.
EP17705072.1A 2016-02-10 2017-02-09 Dispositif de logement de pompe sanguine Active EP3413949B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE1650171 2016-02-10
SE1651606 2016-12-06
PCT/EP2017/052837 WO2017137486A1 (fr) 2016-02-10 2017-02-09 Dispositif de logement de pompe sanguine

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EP3413949A1 true EP3413949A1 (fr) 2018-12-19
EP3413949B1 EP3413949B1 (fr) 2020-10-07

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US (1) US11202902B2 (fr)
EP (1) EP3413949B1 (fr)
JP (1) JP6948335B2 (fr)
AU (1) AU2017218033B2 (fr)
CA (1) CA3014105C (fr)
WO (1) WO2017137486A1 (fr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019070500A1 (fr) * 2017-10-04 2019-04-11 Heartware, Inc. Dispositif d'assistance circulatoire à piston d'entraînement du sang en suspension magnétique
US11690997B2 (en) 2018-04-06 2023-07-04 Puzzle Medical Devices Inc. Mammalian body conduit intralumenal device and lumen wall anchor assembly, components thereof and methods of implantation and explanation thereof
WO2019191851A1 (fr) * 2018-04-06 2019-10-10 Georges Gabriel Système et procédé d'assistance à la circulation de fluide
US11179557B2 (en) 2019-03-26 2021-11-23 Puzzle Medical Devices Inc. Modular mammalian body implantable fluid flow influencing device and related methods
JP2023518426A (ja) 2020-03-18 2023-05-01 スカンジナビアン・リアル・ハート・アクチエボラーグ 圧力センサ配置および方法

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Publication number Priority date Publication date Assignee Title
US3608088A (en) * 1969-04-17 1971-09-28 Univ Minnesota Implantable blood pump
US4863461A (en) * 1988-03-21 1989-09-05 Symbion, Inc. Artificial ventricle
US5676651A (en) * 1992-08-06 1997-10-14 Electric Boat Corporation Surgically implantable pump arrangement and method for pumping body fluids
US20060253194A1 (en) * 2005-05-05 2006-11-09 Dial Discoveries, Llc Devices and methods for displacing biological fluids incorporating stacked disc impeller systems
PT2026856E (pt) 2006-05-31 2015-11-24 Vadovations Inc Dispositivo de assistência cardíaca
US20090287305A1 (en) * 2008-05-19 2009-11-19 Amalaha Leonard D Wholly implantable non-natural heart for humans
US8419789B2 (en) * 2010-11-23 2013-04-16 Patentsplus Llc Artificial heart
US8876686B2 (en) * 2011-02-18 2014-11-04 Vascor, Inc Control of blood flow assist systems
SE538251C2 (sv) 2014-08-07 2016-04-19 Scandinavian Real Heart Ab Total artificial heart implant

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Publication number Publication date
US20190038821A1 (en) 2019-02-07
JP2019506238A (ja) 2019-03-07
US11202902B2 (en) 2021-12-21
JP6948335B2 (ja) 2021-10-13
CA3014105A1 (fr) 2017-08-17
AU2017218033B2 (en) 2021-05-20
WO2017137486A1 (fr) 2017-08-17
CA3014105C (fr) 2024-06-11
EP3413949B1 (fr) 2020-10-07
AU2017218033A1 (en) 2018-08-16

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